Tulane University School of Medicine is consulting the people of Greater New Orleans area whether to lead a local trauma research study to investigate a blood clotting agent as a treatment for trauma patients who are bleeding to death.
Bleeding out is the most common cause of preventable death after injury. Researchers at Tulane University School of Medicine are asking for community input on whether they should participate in an international study. The study will see if a blood clotting drug, given soon after arrival in the emergency department, can improve survival.
Kcentra® (or 4-factor Prothrombin Complex Concentrate) is a Food and Drug Administration (FDA) approved drug and is currently used to reverse the effects of medications given to “thin” the blood, for patients who experience bleeding and/or require surgery.
The Trauma and Prothrombin Complex Concentrate or TAP Trial will evaluate the effectiveness of Kcentra®, in addition to all standard care, in injured patients predicted to require a large volume blood transfusion. “There is evidence that Kcentra® may reduce the chance of dying in injured patients who are not on blood-thinning medications,” explains Dr. Juan Duchesne a trauma surgeon at the Norman McSwain Level I Trauma Center at University Medical Center New Orleans and Section Chief of Trauma/Acute Care and Critical Care at Tulane University School of Medicine.
“The standard treatment of injured patients who are bleeding involves the transfusion of different types of blood products, as well as the use of medications to help the blood clot better, along with surgery to stop the bleeding. But even with these treatments up to 30% of patients suffering from a serious traumatic injury die,” said Dr. Duchesne. “Finding a way to improve that survival rate is our highest priority here at Tulane University and University Medical Center New Orleans.”
Patients in this study will have suffered a serious and potentially life-threatening injury, causing significant blood loss, and requiring immediate lifesaving interventions. These types of injuries occur unexpectedly, and it will not be possible for most people to sign up to participate ahead of time. Most patients will be unconscious, unable to speak or hear, and too sick to consent to immediate treatment, or participation in the study. If the community feedback is positive and an independent review board (IRB) approves the study at Tulane University School of Medicine, then Tulane will participate in this trial. Community members who do not want to participate can request a bracelet indicating this. If feasible, doctors will consent patients who fit the study criteria. If consent is not feasible, patients who fit the criteria will be automatically enrolled without their individual consent if they are not wearing an opt-out bracelet.
The TAP trial will be conducted in about 120 leading trauma centers in several countries and will include 8,000 patients, making it the second-largest trauma trial ever conducted. The trial will begin between early 2023 and last until 2026, and is funded by CSL Behring, a global biotherapeutics leader which makes PCC.
“The results of this study have the potential to change the way trauma patients are treated,” said Dr. Duchesne. “If we can determine that Kcentra® is safe and effective for trauma patients, we can transform the standard of care for bleeding trauma patients and save thousands of lives.”
The researchers are asking for feedback from the Tulane University and University Medical Center New Orleans community about this study to help determine whether the community wants us to participate in this study. Please consider completing a very brief anonymous survey hosted by the local study site. To complete the anonymous survey on your thoughts about this exception from informed consent study, please go to https://www.uab.edu/medicine/cis/tap-trial-at-tulane
Researchers will host informational sessions via Zoom. These sessions will immediately follow the informational sessions about the TROOP study.
This forum will be hosted on:
Thursday, August 17, at 12:30
Tuesday, August 17, at 6:30 pm
You will have a chance to speak with the physician leading this trial, ask questions, and learn about trauma research.
People who want to opt out and receive a bracelet will need to contact Tulane at 504-988-5272 to schedule a time to pick up bracelets.